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Improving PMTCT uptake and retention services through novel approaches in peer-based family-supported care in the clinic and community: a 3-arm cluster randomized trial (PURE Malawi).

ABSTRACT: In July 2011, Malawi introduced an ambitious public health program known as "Option B+," which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of clinical stage or CD4 count. Option B+ is expected to have benefits for HIV-infected women, their HIV-exposed infants, and their HIV-uninfected male sex partners. However, these benefits hinge on early uptake of prevention of mother-to-child transmission, good adherence, and long-term retention in care. The Prevention of mother-to-child transmission Uptake and REtention (PURE) study is a 3-arm cluster randomized controlled trial to evaluate whether clinic- or community-based peer support will improve care-seeking and retention in care by HIV-infected pregnant and breastfeeding women, their HIV-exposed infants, and their male sex partners, and ultimately improve health outcomes in all 3 populations. We describe the PURE Malawi Consortium, the initial work conducted to inform the trial and interventions, the trial design, and the analysis plan. We then discuss concerns and expected contributions to Malawi and the region.

SUBMITTER: Rosenberg NE

PROVIDER: S-EPMC4197136 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Improving PMTCT uptake and retention services through novel approaches in peer-based family-supported care in the clinic and community: a 3-arm cluster randomized trial (PURE Malawi).

Rosenberg Nora E NE van Lettow Monique M Tweya Hannock H Kapito-Tembo Atupele A Bourdon Cassandre Man CM Cataldo Fabian F Chiwaula Levison L Sampathkumar Veena V Trapence Clement C Kayoyo Virginia V Kasende Florence F Kaunda Blessings B Speight Colin C Schouten Erik E Eliya Michael M Hosseinipour Mina M Phiri Sam S

Journal of acquired immune deficiency syndromes (1999) 20141101

In July 2011, Malawi introduced an ambitious public health program known as "Option B+," which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of clinical stage or CD4 count. Option B+ is expected to have benefits for HIV-infected women, their HIV-exposed infants, and their HIV-uninfected male sex partners. However, these benefits hinge on early uptake of prevention of mother-to-child transmission, good adherence, and long-t ...[more]

PMID: 25310116

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Project description:BackgroundMalawi introduced an ambitious public health program known as "Option B+" which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of WHO clinical stage or CD4 cell count. The PMTCT Uptake and REtention (PURE) study aimed at evaluating the effect of peer-support on care-seeking and retention in care.Methods/designPURE Malawi was a three-arm cluster randomized controlled trial that compared facility-based and community-based models of peer support to standard of care under Option B+ strategy. Each arm was expected to enroll a minimum of 360 women with a total minimum sample size of 1080 participants. 21 sites (clusters) were selected for inclusion in the study. This paper describes the site selection, recruitment, enrollment process and baseline characteristics of study sites and women enrolled in the trial.ResultsStudy implementation was managed by 3 partner organizations; each responsible for 7 study sites. The trial was conducted in the South East, South West, and Central West zones of Malawi, the zones where the implementing partners operate. Study sites included 2 district hospitals, 2 mission hospitals, 2 rural hospitals, 13 health centers and 1 private clinic. Enrollment occurred from November 2013 to November 2014, over a median period of 31 weeks (range 17-51) by site. A total of 1269 HIV-infected pregnant (1094) and breastfeeding (175) women, who were eligible to initiate ART under Option B+, were enrolled. Each site reached or surpassed the minimum sample size. Comparing the number of women enrolled versus antenatal cohort reports, sites recruited a median of 90% (IQR 75-100) of eligible reported women. In the majority of sites the ratio of pregnant and lactating women enrolled in the study was similar to the ratio of reported pregnant and lactating women starting ART in the same sites. The median age of all women was 27 (IQR 22-31) years. All women have ≥20 months of possible follow-up time; 96% ≥ 2 years (24-32 months).ConclusionThe PURE Malawi study showed that 3 implementing partner organizations could successfully recruit a complex cohort of pregnant and lactating women across 3 geographical zones in Malawi within a reasonable timeline.Trial registrationThis study is registered at clinicaltrials.gov - ID Number NCT02005835 . Registered 4 December, 2013.

Project description:BackgroundPrevention of mother-to-child transmission of HIV (PMTCT) is effective in curbing rates of HIV infection in children because its interventions reduce the rates of transmission during pregnancy, in labour, and in breastfeeding. Male involvement (MI) greatly influences uptake and adherence to PMTCT services. Lack of clarity on the roles and expectations of men in PMTCT is one of the main barriers to MI. The main aim of the study was to explore the roles and expectations of male partners from PMTCT services in Malawi.MethodsThis was a descriptive qualitative study that involved men whose partners were either pregnant or breastfeeding a child, health care workers working in PMTCT services for over six months, and traditional leaders. We conducted 9 in-depth interviews and 12 key informant interviews from January to March 2018. All interviews were audio-recorded, transcribed, and translated. Thematic analysis was employed to analyze data.ResultsThe subjective and community norms and attitudes of men towards PMTCT provide the context in which male partners define the specific roles they render and the services they expect from PMTCT services. The roles of men in PMTCT service were contextualized in what is socially acceptable and normalized in the setting and include supportive roles expressed as accompanying the wife to attend; antenatal care services, Dry blood sample collection (DBS) when its due, keeping appointments when is due to take the ARVs, providing financial support; HIV prevention behavior change and decision-making roles. The desired services within PMTCT include health assessment such as checking their weight; blood pressure; blood sugar and promotion activities such as education sessions that are provided in a male-friendly manner that is in tandem with existing socio-cultural norms and attitudes of men towards such services.ConclusionThe roles of male partners in PMTCT services are underpinned by subjective norms and what is socially acceptable within a specific context. The services that men require from PMTCT services are influenced by their attitudes and beliefs towards PMTCT interventions. Services should be male-tailored provided in an atmosphere that allows and accepts male partners to exercise their roles in PMTCT services.

Project description:INTRODUCTION:Definitions of retention-in-care in Prevention of Mother-to-Child Transmission of HIV (PMTCT) vary substantially between studies and programmes. Some definitions are based on visits missed/made, others on a minimum total number of visits, or attendance at a final clinic visit at a specific time. An agreed definition could contribute to developing evidence-based interventions for improving retention-in-care. In this paper, we estimated retention-in-care rates according to different definitions, and we quantified and visualized the degree of agreement between definitions. METHODS:We calculated retention in care rates using nine definitions in the six INSPIRE PMTCT intervention studies, conducted in three sub-Saharan African countries between 2013 and 2017. With data from one of the studies (E4E), we estimated the agreement between definitions using Gwet's agreement coefficient (AC1) and concordance. We calculated positive predictive values (PPV) and negative predictive values (NPV) for all definitions considering successively each definition as the reference standard. Finally, we used a Multiple Correspondence Analysis (MCA) to examine clustering of the way different definitions handle retention-in-care. RESULTS:Retention-in-care rates among 5107 women ranged from 30% to 76% in the complete dataset with Gwet's AC1 being 0.56 [0.53; 0.59] indicating a moderate agreement between all definitions together. Two pairs of definitions with high inner concordance and agreement had either very high PPV or very high NPV, and appeared distinct from the other five definitions on the MCA figures. These pairs of definitions were also the ones resulting in the lowest and highest estimates of retention-in-care. The simplest definition, that only required a final clinic visit to classify women as retained in care, and classified 55% of women as retained in care, had a PPV ranging from 0.7 to 1 and a NPV ranging from 0.69 to 0.98 when excluding the two pairs afore-mentioned; it resulted in a moderate to substantial agreement and a 70% to 90% concordance with all other definitions. CONCLUSIONS:Our study highlights the variability of definitions in estimating retention-in-care. Some definitions are very stringent which may be required in some instances. A simple indicator such as attendance at a single time point may be sufficient for programme planning and evaluation.

Project description:BackgroundHIV-positive mothers who face the dual burden of HIV-positive status and motherhood, may benefit from holistic services that include early childhood development (ECD). We evaluated the acceptability and impact of integrated ECD-PMTCT interventions for mothers and their children.MethodsWe implemented an integrated ECD-PMTCT intervention in 4 health facilities in Malawi for HIV-positive mothers and their infants. WHO/UNICEF Care for Child Development (CCD) education and counseling sessions were offered during routine PMTCT visits between infant age 1.5-24 months. From June-July 2019, we conducted in-depth interviews with 29 mothers enrolled in the intervention for ≥6 months across 4 health facilities. The interview guide focused on perceived impact of the intervention on mothers' ECD and PMTCT practices, including barriers and facilitators, and unmet needs related to the program. Data were coded and analyzed using constant comparison methods in Atlas ti.8.ResultsThe vast majority of mothers believed the ECD-PMTCT intervention improved their overall experience with the PMTCT services, strengthened their relationship with providers, and excited and motivated them to attend PMTCT services during the postpartum period. Unlike prior experience, mothers felt more welcome at the health facility, and looked forward to the next visit in order to interact with other mothers and learn new ECD skills. Mothers formed new social support networks with other mothers engaged in ECD sessions, and they provided emotional and financial support to one another, including encouragement regarding ART adherence. Mothers believed their infants reached developmental milestones faster compared to non-intervention children they observed at the same age, and they experienced improved engagement in caregiving activities among male caregivers. Nearly half of women requested additional support with depression or anxiety, coping mechanisms to deal with the stresses of life, or support in building positive dynamics with their male partner.ConclusionThe integrated ECD-PMTCT intervention improved mother's experiences with PMTCT programs and health care providers, increased ECD practices such as responsive and stimulating parenting, and created social support networks for women with other PMTCT clients.

Project description:BackgroundLittle is known about how to build leadership capacity to support implementation of evidence-based practices within health systems. We observed substantial variability across sites in uptake and sustainability of a peer-led educational outreach intervention for lay health workers (LHWs) providing tuberculosis care in Malawi. Feedback from peer-trainers (PTs) suggested that leadership may have contributed to the variation. We sought to assess the impact of PT leadership style on implementation, and to identify leadership traits of more successful PTs, to inform future implementation planning and to identify targets for leadership capacity building.MethodsQualitative study employing interviews with PTs and LHWs at high and low implementation sites, and review of study team and quarterly PT meeting notes. High implementation sites achieved high uptake, sustainability and fidelity of implementation including: close adherence to training content and process, high levels of coverage (training most or all eligible LHWs at their site), and outcomes were achieved with high levels of self reported competence with the intervention among both PTs and LHWs. Low implementation sites achieved limited coverage (<= 50% of LHWs trained), and intervention fidelity.ResultsEight PTs and 10 LHWs from eight high and 10 low implementation sites participated in interviews. Leadership traits of more successful PTs included: flexibility in their approach to training, role modeling and provision of supportive supervision to support learning; addressing challenges proactively and as they occurred; collaborative planning; knowledgeable; and availability to support implementation. Traits unique to less successful PTs included: a poor attitude toward their role as PT and a passive-avoidant approach to challenges.ConclusionThis study identified leadership traits more common among unit level leaders at sites with higher uptake, sustainability, and fidelity of implementation. These findings provide a starting point for development and evaluation of a leadership capacity building intervention for unit level leaders to support implementation.

Project description:BackgroundPregnant and postpartum women living with HIV (WLWH) need support for HIV and maternal child health (MCH) care, which could be provided using short message service (SMS).Methods and findingsWe compared 2-way (interactive) and 1-way SMS messaging to no SMS in a 3-arm randomized trial in 6 MCH clinics in Kenya. Messages were developed using the Health Belief Model and Social Cognitive Theory; HIV messages were integrated into an existing MCH SMS platform. Intervention participants received visit reminders and prespecified weekly SMS on antiretroviral therapy (ART) adherence and MCH, tailored to their characteristics and timing. Two-way participants could message nurses as needed. Clinic attendance, viral load (VL), and infant HIV results were abstracted from program records. Primary outcomes were viral nonsuppression (VL ≥1,000 c/ml), on-time clinic attendance, loss to follow-up from clinical care, and infant HIV-free survival. Among 824 pregnant women randomized between November 2015 and May 2017, median age was 27 years, gestational age was 24.3 weeks, and time since initiation of ART was 1.0 year. During follow-up to 2 years postpartum, 9.8% of 3,150 VL assessments and 19.6% of women were ever nonsuppressed, with no significant difference in 1-way versus control (11.2% versus 9.6%, adjusted risk ratio (aRR) 1.02 [95% confidence interval (CI) 0.67 to 1.54], p = 0.94) or 2-way versus control (8.5% versus 9.6%, aRR 0.80 [95% CI 0.52 to 1.23], p = 0.31). Median ART adherence and incident ART resistance did not significantly differ by arm. Overall, 88.9% (95% CI 76.5 to 95.7) of visits were on time, with no significant differences between arms (88.2% in control versus 88.6% in 1-way and 88.8% in 2-way). Incidence of infant HIV or death was 3.01/100 person-years (py), with no significant difference between arms; risk of infant HIV infection was 0.94%. Time to postpartum contraception was significantly shorter in the 2-way arm than control. Study limitations include limited ability to detect improvement due to high viral suppression and visit attendance and imperfect synchronization of SMS reminders to clinic visits.ConclusionsIntegrated HIV/MCH messaging did not improve HIV outcomes but was associated with improved initiation of postpartum contraception. In programs where most women are virally suppressed, targeted SMS informed by VL data may improve effectiveness. Rigorous evaluation remains important to optimize mobile health (mHealth) interventions.Trial registrationClinicalTrials.gov number NCT02400671.

Dataset Information

Improving PMTCT uptake and retention services through novel approaches in peer-based family-supported care in the clinic and community: a 3-arm cluster randomized trial (PURE Malawi).

Publications

Improving PMTCT uptake and retention services through novel approaches in peer-based family-supported care in the clinic and community: a 3-arm cluster randomized trial (PURE Malawi).

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